Electrical stimulator for peripheral stimulation

ABSTRACT

Neurostimulation assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles and/or nerves inside the body and stimulus generators and/or recording instruments mounted on the surface of the skin or carried outside the body. The assembly affords maximum patient mobility and comfort through differentiated components having minimal profiles and connected by way of detachable and adjustable connections.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Utility application Ser. No.15/822,768 filed on Nov. 27, 2017, which is a continuation of U.S.Utility application Ser. No. 14/953,099 filed on Nov. 27, 2015, now U.S.Pat. No. 9,827,419, which claims priority to U.S. Patent ApplicationSer. No. 62/084,744 filed on Nov. 26, 2014. The disclosure of theseapplications, along with any other United States Patents and UnitedStates Patent Publications identified in this specification, are herebyincorporated by reference.

FIELD OF USE

The present disclosure generally relates to an electrical stimulatorand, more particularly, a mobile, electrical stimulator system forperipheral electrical stimulation.

BACKGROUND

Neurostimulation and brain stimulation can provide functional and/ortherapeutic outcomes. While existing systems and methods providebenefits to individuals requiring neurostimulation, many quality of lifeissues still remain. For example, existing systems are performed solelyin a clinical setting under the supervision of a clinician limiting theapplicable uses and the time available for stimulation. Furthermore, thecontrollers utilized in these clinical settings, by today's standards,are relatively large and awkward to manipulate and transport.

There exist both external and implantable devices for providingneurostimulation in diverse therapeutic and functional restorationindications. These neurostimulators are able to provide treatmenttherapy to individual portions of the body. The operation of thesedevices typically includes use of an electrode placed either on theexternal surface of the skin and/or a surgically implanted electrode. Inthe case of external neurostimulators, surface electrodes and/orpercutaneous lead(s) having one or more electrodes are used to deliverelectrical stimulation to select portion(s) of the patient's body.

For example, transcutaneous electrical nerve stimulation (“TENS”) isdelivered through electrodes placed on the skin surface, but has notachieved widespread use due to discomfort of the therapy, musclefatigue, and the limited efficacy. TENS is similar to electrical musclestimulation, although the latter is intended for stimulating musclesrather than nerves.

Several clinical and technical issues associated with surface electricalstimulation have prevented it from becoming a widely accepted treatmentmethod. First, stimulation of cutaneous pain receptors cannot be avoidedresulting in stimulation-induced pain that limits patient tolerance andcompliance. Second, electrical stimulation is delivered at a relativelyhigh frequency to prevent stimulation-induced pain, which leads to earlyonset of muscle fatigue. Third, it is difficult to stimulate deep nerveswith surface electrodes without stimulating overlying, more superficialnerves resulting in unwanted stimulation. Further still, clinical skilland intensive patient training is required to place surface electrodesreliably on a daily basis and adjust stimulation parameters to provideoptimal treatment. The required daily maintenance and adjustment of asurface electrical stimulation system is a major burden on both patientand caregiver.

A number of previous systems for spinal cord stimulation (e.g., at thedorsal root ganglion) and/or other deep tissue stimulation requiresurgical implantation of electrodes and/or other devices for deliveringthe therapy. These therapies necessarily incur the cost and medicalrisks associated with invasive surgical procedures, and they mayrestrict the mobility of the patient, both in terms of the surgicalprocedure itself and, in some cases, in the post-operative activities anambulatory patient may wish to engage in while in his or her homeenvironment.

Moreover, many previous stimulation systems require complex engagementsystems to operatively attach a lead with a stimulator. These systemsoften require separate tools to operatively attach the lead with thestimulator, require more than one person to accomplish, or are difficultto operatively attach. Often a connector is utilized to operativelyattach the lead with the stimulator. These connectors are oftenuncomfortable for the patient to wear, require significant dexterityfrom the clinician to attach and/or require additional tools to attach.

U.S. Pat. Nos. 6,845,271 and 8,249,713 describe methods of treatingshoulder dysfunction by way of percutaneous, electrical stimulation.Specific, asynchronous stimulation profiles are delivered via aplurality of spiral or helix wire electrodes with terminal barbsinserted into the targeted muscles. The electrodes may be inserted by ahypodermic needle or surgical procedure.

U.S. Pat. No. 7,376,467 discloses a neuromuscular stimulation assemblyincluding a steerable introducer defining an interior lumen that shieldsthe electrode from contact with tissue during insertion. Electrodessuitable for this assembly may be transcutaneous or percutaneous. Theassembly includes a carrier, adhesively held to the patient, having anelectronics pod for generating the desired electrical current patternsand an optional power input bay to enable changing the batteries for theassembly. Electrical connections between the electrodes and the powersource are established via troughs that are integrally formed on thepod.

U.S. Pat. No. 8,463,383 contemplates neurostimulation assemblies forshort-term therapy or diagnostic testing via a fine wire electrode. Theassembly includes a carrier and an optionally removable electronics podassociated with that carrier. The pod generates the stimulating pulsesand includes user interface components. A power source and optionalmemory unit are contained within the assembly and, more specifically,possibly within the return electrode itself.

U.S. Pat. Nos. 8,626,302 and 8,954,153 and United States PatentPublication 2013/0238066 disclose methods of alleviating pain viapercutaneous and/or peripheral nerve electrical stimulation. As withother methods noted above, a hypodermic needle and lumen combination maydeliver the lead. Various stimulation parameters are disclosed therein.

U.S. Pat. No. 8,700,177 describes a system and method involving the useof an adhesive patch with a mounting structure directly mated to anelectrical stimulation device. A percutaneous electrode is electricallycoupled to the stimulation device. The device has a low profile and maybe controlled wirelessly or by way of a plugged connection. Arechargeable battery powers the device, which may be inductivelycharged.

SUMMARY

A compact, mobile system for peripheral electrical nerve stimulation isdisclosed. This system allows for the targeted delivery of stimulationwhile bypassing cutaneous pain receptors and without the need for openor invasive surgical procedures. The system allows for a relatively widerange of possible pulse profiles, while reducing the risk of musclefatigue and minimizing the need for patients to rely on skilledpersonnel to maintain or monitor the system.

One particularly relevant aspect of the system is that it includes oneor more “breakaway” connections to ensure that the electrode and/or leaddoes not become dislodged in the event of inadvertent or unwanted forcesbeing applied to the lead or its connections, e.g., application of apredefined force causes the patient cable (or lead) to break away fromthe stimulator. These breakaway connections may fully disconnect and/orsimply reduce the tension of the connections to ensure that theelectrode is unaffected. Further, the system can provide an alert to theuser in the event of disconnection or reduction in tension so that theuser can confirm the system is still in operational. These features,whether considered singly or in combination, prevent the user from beingconfined to a clinician's office (or other restricted movement/accessareas) during the treatment and, instead, allow the user to engage ineveryday activities.

The system is easier to use for the patient and allows the clinician toaffix it to the patient. The system does not require tools tooperatively attach the lead with the stimulator. Further still thesystem may allow a clinician to only use a single hand to operativelyconnect the system together.

Another aspect of the system is that it may be lightweight, has agenerally low profile and is adaptable. In particular, after theelectrode is positioned within the body, the combination of the adhesivebandage, the lead connector and the patient cable may allow the user toadjustably position the stimulator pod in a convenient position on hisor her body. The lead connector and other system elements may beaugmented to accommodate multiple electrodes, thereby enablingcoordinated therapies across regions of the body. The system elementsmay be wirelessly connected to minimize physical connections andmaximize user comfort.

Additionally, the stimulator pod and controller pod may be furtheraugmented through use of a programmer unit during the treatment, so thatthe clinician or even the user can directly control the process.

As noted above, the breakaway feature may permit disconnection of thepatient cable from the stimulator pod when a predefined force isapplied. The system on the body may maintain sufficient attachment forcebetween the lead and stimulator pod to remain operatively connectedduring a wide range of patient activities during which therapy may beneeded. At the same time, the system may be able to disconnect thepatient cable from the stimulator pod safely and/or comfortably withoutdamaging and/or displacing the system and/or any of its components (e.g.lead, connectors, stimulator, pad, etc.) and/or without injuring orcausing pain or discomfort to the patient. In other words, the systempermits the connection between the patient cable and stimulator pod toremain mechanically and electrically connected when desired but also mayenable safe disconnection when necessary (such as mechanically and/orelectrically). This may also enable a patient to reconnect withoutclinician support (enables patient to safely resume therapy withouthaving to return to clinician to have a lead, system, or other systemcomponent repaired, replaced, reprogrammed, and/or repositioned). Inaddition to protecting the lead connector (and the attached percutaneouslead) from accidental forces on the patient cable from catching orsnagging on clothing, handled objects, or objects in the environment.

Specific embodiments of the present teachings may include anycombination of the following features:

-   -   a helical, wire electrode, carried within an introducer (e.g., a        disposable hypodermic needle or sheath);    -   an adhesive patch at least partially securing a proximal end of        the electrode protruding from the body;    -   a lead connector, fixed to the proximal end of the electrode;    -   a patient cable detachably connected to the lead connector;    -   a stimulator pod, including a power source and a return        electrode, detachably connected to the patient cable and forming        an electrical connection between the pod and the electrode to        deliver therapeutic stimulation;    -   a controller pod in communication with the stimulator pod;    -   a programmer unit in communication in the controller pod and/or        stimulator pod wherein the programmer unit selectively delivers        instructions to inform the therapeutic stimulation;    -   wherein the electrode, the lead connector, patient cable and        stimulator pod form a series of detachable connections having        tension and, in response to a disconnection force, at least one        of the following occurs: the tension is temporarily reduced and        the patient cable detaches from the lead connector;    -   wherein at least one of the detachable connections is        established by way of at least one selected from: a magnet and a        releasable, spring-loaded connection, a connector having a        predefined holding strength;    -   wherein the programmer unit communicates with the controller pod        by way of a wireless connection;    -   wherein the needle includes at least one test stimulation        electrodes, controlled by the controller pod to aid in the        positioning of the electrode;    -   wherein the needle includes at least one test stimulation        electrodes, controlled by at least one of the controller pod and        the programmer pod to aid in the positioning of the electrode;    -   wherein the lead connector is bifurcated to enable connection of        a plurality of electrodes;    -   wherein the patient cable comprises a plurality of segments in        which each segment is detachably connected;    -   wherein a plurality of stimulator pods may be provided in        combination with a plurality of electrodes and wherein the        controller pod coordinates stimulation among the stimulator        pods;    -   wherein the stimulator pods communicate wirelessly with the        controller pod;    -   wherein the lead connection further comprises a mechanical        connector that receives and holds the proximal end while        maintaining an electrical connection between the electrode and        the patient cable;    -   wherein the mechanical connector releasably and resettably moves        in response to the force;    -   wherein the lead connector mechanically secures the lead and        electrically connects to it in response to a force applied by        the user;    -   wherein the mechanical connector comprises a rotating element;    -   wherein the mechanical connector comprises a funnel that may        have a controllably collapsible segment and wherein the proximal        end of the lead received through said funnel and said        controllably collapsible segment engages a portion of the        electrode close to the proximal end;    -   wherein the rotating element of the lead connector is        electrically connected to the lead and to the series of        detachable connections ending at the stimulator pod;    -   wherein at least one of the stimulator pod and the controller        pod provide a user alert when a predetermined amount of force is        applied, e.g., an amount to dislodge the patient cable;    -   wherein the user alert includes at least one of the following: a        visual cue and an auditory cue;    -   wherein the magnet comprises at least one insert molded        neodymium magnet;    -   wherein the magnet is shielded to reduce unintended magnetic        fields and concentrate or focus the filed between the two ends        of the breakaway mechanism;    -   wherein the tension is reduced to a predetermined level and,        upon the force exceeding the predetermined level, the patient        cable detaches;    -   wherein the predetermined level is less than or equal to a        fraction (e.g., one half, 90%, 80%, 70% etc.) of a force        required to change position of the lead connector on the body;    -   wherein at least one end of the patient cable includes a        connection member that is mated to a corresponding connection        member on at least one of the lead connector and the stimulator        pod; and    -   wherein there may be a plurality of mated connection members and        each set of mated members has a unique shape to avoid improper        connections.

A percutaneous electrical stimulator system may include an electrodepercutaneously insertable into a patient, an adhesive bandage at leastpartially securing a proximal end of the electrode protruding from thepatient, a lead connector, fixed to the proximal end of the electrode, apatient cable detachably connected to the lead connector, and astimulator connected to the patient cable and forming an electricalconnection between the stimulator and the electrode to delivertherapeutic stimulation.

The percutaneous electrical stimulator system describe above:

-   -   wherein the electrode, the lead connector and the patient cable        form a series of detachable connections having tension and, in        response to a disconnection force, at least one of the following        occurs: the tension is temporarily reduced and the patient cable        detaches.    -   wherein at least one of the detachable connections is        established by way of at least one selected from: a magnet and a        releasable, spring-loaded connection, a mechanical connection.    -   wherein a portion of the series of detachable connections is        engaged via a rotating element, said rotating element adjusting        the tension in response to the disconnection force.    -   further comprising a controller in communication with the        stimulator.    -   wherein the stimulator communicates wirelessly with the        controller.    -   further comprising a programmer unit in communication with the        controller wherein the programmer unit selectively delivers        instructions to inform the therapeutic stimulation.    -   wherein the programmer unit communicates with the controller by        way of a wireless connection.    -   wherein at least one of the stimulator and the controller        provide a user alert when the response to the force occurs.    -   wherein the user alert includes at least one of the following: a        visual cue, tactile cue and an auditory cue.    -   further comprising a programmer unit in communication with the        stimulator, wherein the programmer unit selectively delivers        instructions to inform the therapeutic stimulation.    -   wherein the lead connector is plurally split to enable        connection of a plurality of electrodes.    -   wherein the patient cable comprises a plurality of segments in        which each segment is detachably connected.    -   wherein a plurality of stimulators are provided in combination        with a plurality of electrodes and wherein the controller        coordinates stimulation among the stimulator.    -   wherein the stimulators communicate wirelessly with the        controller.    -   wherein the lead connection further comprises a mechanical        connector that receives and holds the proximal end while        maintaining an electrical connection between the electrode and        the patient cable.    -   wherein the mechanical connector releasably and resettably moves        in response to the disconnection force.    -   wherein the mechanical connector comprises a rotating element.    -   wherein the mechanical connector comprises a funnel with a        controllably collapsible segment and wherein the proximal end        received through said funnel and said controllably collapsible        segment engages a portion of the electrode proximate to the        proximal end.    -   wherein the magnet comprises at least one insert molded magnet        formed from at least one of neodymium, samarium cobalt, alnico,        and ferrite.    -   wherein the magnet is shielded to reduce unintended magnetic        fields and/or to concentrate intended magnetic fields from the        magnet.    -   wherein the tension is reduced to a predetermined level and,        upon the disconnection force exceeding the predetermined level,        the patient cable detaches.    -   wherein the predetermined level is less than or equal to a        percentage of force required to change position of the electrode        within the patient.    -   wherein at least one end of the patient cable includes a        connection member that is mated to a corresponding connection        member on at least one of the lead connector and the stimulator.    -   wherein there are a plurality of mated connection members and        each set of mated members has a unique shape to avoid improper        connections.

A percutaneous electrical stimulator system may include an electrodepercutaneously insertable into a patient, a lead extending from theelectrode, a lead connector, fixed to the lead, a patient cabledetachably connected to the lead connector, and a stimulator connectedto the patient cable and forming an electrical connection between thestimulator and the electrode to deliver therapeutic stimulation.

The percutaneous electrical stimulator system describe above:

-   -   wherein the lead is a helical wire lead with the electrode        integrally formed at an end thereof.

A percutaneous electrical stimulator system may include a wire electrodepercutaneously insertable into a patient, the electrode having aproximal end extending from the patient when inserted therein, a leadconnector, fixed to the proximal end of the electrode, a patient cabledetachably connected to the lead connector, a stimulator connected tothe patient cable and forming an electrical connection betweenstimulator and the electrode to deliver therapeutic stimulation.

The percutaneous electrical stimulator system describe above:

-   -   further comprising a controller in communication with the        stimulator wherein the electrode, lead connector and patient        cable form a series of detachable connections having tension        and, in response to a disconnection force, at least one of the        following occurs: the tension is temporarily reduced and the        patient cable detaches.    -   wherein at least one of the detachable connections is        established by way of at least one selected from: a magnet and a        releasable, spring-loaded connection.    -   wherein the electrode is covered by an electrical insulation        except at a distal end thereof.    -   wherein the mechanical connector comprises a rotating element        providing motion and force to cut or pierce the electrical        insulation and to mechanically secure the lead.

These and other features and advantages of the present teachings are setforth in the following specification, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentdisclosure are better understood when the following detailed descriptionis read with reference to the accompanying drawings, in which:

FIG. 1 is a schematic representation of one embodiment of the presentteachings.

FIGS. 2A and 2B illustrate selected components in one embodiment of thepresent teachings.

FIGS. 3A, 3B and 3C are diagrammatic representations of the leadconnector used in various embodiments of the present teachings.

FIGS. 4A and 4B diagrammatically illustrate potential mating connectionsfor the magnets and other detachable connections.

FIG. 5 diagrammatically illustrates a spring-loaded and/or magneticconnection that can be used in the detachable connections.

FIG. 6 is a perspective view of an embodiment of an adhesive bandage ofthe present teachings.

FIG. 7 is a perspective view of an embodiment of an adhesive bandage ofthe present teachings attached to a patient.

FIG. 8 is a perspective view of the adhesive bandage being removed fromthe patient.

FIG. 9 is a perspective view of the patient with a lead inserted at aninsertion site with the lead connector attached to the lead and adhesivebandage removed.

FIG. 10 is a perspective view of the adhesive bandage being attached toa patient.

FIG. 11 is a perspective view of the lead connector operatively attachedwith the stimulator pod through the patient cable with the adhesivebandage attached to the patient.

FIG. 12 are schematic views of embodiments of a lead connector.

FIG. 13 are schematic views of embodiments of a lead connector with leadstorage mechanism.

FIG. 14 are schematic views of embodiments of a lead connector with leadstorage mechanism.

FIG. 15 are schematic views of embodiments of a lead connector.

FIG. 16 are schematic views of embodiments of a lead connector.

FIG. 17 are schematic views of embodiments of a lead connector with astorage device.

FIG. 18 are schematic view of embodiments of the lead connector andstimulator pod with patient cables with breakaway mechanisms.

FIG. 19 are graphical representations of stimulation intensity withamplitude and pulse duration.

FIG. 20 is a perspective view of embodiments of an IDC.

FIG. 21 is a perspective view of embodiments of an IDC.

FIG. 22 is a cross-sectional view of a portion of a breakaway mechanism.

FIG. 23 is a cross-sectional view of a portion of a breakaway mechanism.

FIG. 24 is a cross-sectional view of a breakaway mechanism.

FIG. 25 is a cross-sectional view of a portion of a breakaway mechanism.

DETAILED DESCRIPTION

Reference will now be made in detail to exemplary embodiments of thepresent teachings, examples of which are illustrated in the accompanyingdrawings. It is to be understood that other embodiments may be utilizedand structural and functional changes may be made without departing fromthe respective scope of the present teachings. Moreover, features of thevarious embodiments may be combined or altered in any combinationwithout departing from the scope of the present teachings. As such, thefollowing description is presented by way of illustration only andshould not limit in any way the various alternatives and modificationsthat may be made to the illustrated embodiments and still be within thespirit and scope of the present teachings.

As noted above, previous neurostimulation and neuromodulation systemshave inherent weaknesses. For example, these weaknesses may includedifficulty using the stimulator while it is mounted on difficult toreach position of the body, a position on the body that is subject tofrequent movement, including, without limitation the patient's arm,back, leg, head, shoulder, etc. Further, it may be difficult for aclinician to couple the stimulator with the lead, including, withoutlimitation a fine-wire lead and may be difficult for the clinician towork with the system while on the patient body. Further still anotherweaknesses may include inherent difficulty with operating the systemwhile it is adhered to the body, a complex user interface, difficultyreplacing bandages without fear of dislodging the electrode, anddiscomfort due to system size and shape. Certain embodiments of thepresent teachings overcome these weaknesses and provide additionaladvantages, as will be recognized by persons of skill in this field.

FIG. 1 schematically illustrates components of one embodiment of theinvention. The percutaneous stimulation system 10 may include anelectrode, such as a fine-wire electrode 18. The electrode 18 may beinitially introduced to the body by way of a hypodermic needle (notshown) or any other method of insertion. The present teachings are notlimited to a specified type of insertion method or apparatus. Anyappropriate system may be utilized without departing from the presentteachings. The electrode 18 may include a lead 20 extending therefromsuch as a micro-lead, fine-wire lead or simply lead. The lead 20 maypossess a generally small diameter in comparison to previous systems,with optimal sizes of less than 1.0 mm and, more preferably, less than0.6 mm. Further, the electrode 18 and/or lead 20 may have a generallycoiled or helical structure, rather than a smooth cylinder. However, thepresent teachings are not limited to this structure. Any appropriateconfiguration may be utilized without departing from the presentteachings.

For the sake of clarity, the term “proximal” in the context of thisapplication typically refers to the end of the electrode that is notinserted into the body and “distal” typically refers to the electrodeend that is inserted into the body near the nerves. Depending upon themanufacture of the electrode structure, this proximal end may be wrappedin an insulating or protective coating or wrap. To the extent electricalconnections must be made with the proximal end, the components at issuewill allow for the removal of such coating(s)/wrap(s).

After the electrode 18 is positioned within the body 12 at a desiredtherapeutic location, the proximal end of the electrode may be coveredby an adhesive bandage 22 and attached to a lead connector 30. Theadhesive bandage 22 may have an adhesive to at least partially coverand, in some instances, guide the proximal end toward the lead connector30. The adhesive bandage 22 may take any number of shapes, including,without limitation the shape depicted in FIG. 2A, and the adhesive maybe selectively applied to portions of the periphery to better ensurethat the proximal end is not inadvertently ensnared when making thenecessary connections within the system 10. The adhesive bandage 22 maybe made of any appropriate thin film material, such as polyethylene, andwith one or more optional absorbent pads and/or non-adhesive removaltabs. The adhesive bandage 22 may also be carried on a disposablebacking that may release the adhesive bandage 22 immediately prior toits application on the body 12.

Embodiments of the adhesive bandage 22 are shown in FIGS. 6-11. Theadhesive bandage 22 may eliminate the need for a separate tape to securethe lead connector 30. The adhesive bandage 22 may be an integral systemcomponent that may generally protect the lead 20 exit site by managingexposure to potential contaminants (e.g., water, dirt, pathogens, virus,bacteria, etc.), thus helping to prevent infection of the site. Theadhesive bandage 22 may further generally protect the lead 20 and morespecifically the electrode 18 from accidental dislodgement caused bysnagging (e.g., on a body part, clothing or furnishings). The adhesivebandage 22 may also generally secure the lead connector 30 to thepatient's skin to isolate the lead 20 from forces applied to the leadconnector 30, such as during system 10 maintenance and daily activitiesof living. The adhesive bandage 22 may be a covering bandage thatintegrates with the lead connector 30 to allow the user to easily andconsistently remove and replace the adhesive bandage 22 without fear ofinadvertently pulling the lead 20 and/or electrode 18. The adhesivebandage 22 may include a film body 42 and skin adhesive 44 that ensuresthat adhesion to skin will be appropriate for use on human skin. Thefilm body 42 may be of any appropriate material, including, withoutlimitation a clear polyethylene or any other material that generallyprotects a wound and discourages infection. The adhesive bandage 22 maybe of any appropriate shape, including, without limitation a generallyelliptical shape. The skin adhesive 44 may be applied along theperimeter such that the lead 20 is not exposed to any skin adhesive 44.The skin adhesive may 44 may have the appropriate amount of tackiness togenerally prevent inadvertent release from the skin. The skin adhesive44 may extend generally around the perimeter of the film body 42 of theadhesive bandage 22. This may create a seal to generally preventcontaminants from entering anywhere around the entire perimeter.Further, this may make the adhesive bandage 22 easier to remove so thatit does not stick to the lead 20 upon removal.

The adhesive bandage 22 may include a cutout section 48 over the leadconnector 30 that may eliminate gaps in the seal and allows the user touse a finger to hold the lead connector 30 firmly against the skinduring replacement of the adhesive bandage 22. As noted above, the leadconnector 30 and adhesive bandage 22 may be contoured to fittogether—this may result in a better seal. The adhesive bandage 22 mayinclude a removal tab 56. A patient and/or clinician can put his or herfinger over the bandage portion 52 and lead connector 30 to generallyprevent the lead 20 and electrode 18 from pulling from the skin. Thismay be particularly useful in difficult to reach positions on thepatients body and on body parts with frequent movement, e.g., legs,arms, back, head, etc.

The film body 42 of the adhesive bandage 22 may include a generallysee-through, translucent, clear, etc. body with a bandage portion 52.The bandage portion 52 may include an absorbent pad configured togenerally absorb any fluid exiting the lead insertion site, e.g., anykind of liquid (including, without limitation, blood) that may ooze fromthe lead insertion site will be absorbed into the bandage portion 52.The size of the bandage portion 52 may still allow the patient and/orclinician to view the area around the lead exit site to determine theexistence of any infections. Having the clear film body 42 furtherallows the patient and/or clinician to view the lead exit site. Theadhesive bandage 22 may help keep fluid from obstructing a view of theskin to help identify if any infections are present on the patient.

Further, the proximal end of the electrode 18 or lead 20 may be receivedby and coupled to the lead connector 30. The lead 20 is fed into thelead connector 30 via a slot 62, funnel 71 or other guide, as generallydepicted by the arrows in FIGS. 3A and 3B. Once the lead 20 is received,coupling may occur compressively by collapsing a portion of thestructure, using a screw, a sliding plate, a lever, friction fit,bayonet, magnet, gripping tabs or other physical means that allow a userto couple the pieces with only one hand. Upon collapse or compression,the lead connector 30 may be fixed to the proximal end of the electrode18 or lead 20. In some embodiments, the lead connector 30 may includegripping teeth, blades or other implements that enhance an interferenceor friction to securely grip the lead 20. In some cases, the elementconnecting the lead connector 30 to the electrode 18 may also serve toremove unwanted insulation or coatings from the surface of the proximalend of the electrode 18, thereby improving both the mechanical andelectrical contact established by lead connector 30. The lead connector30 may fix the lead 20 in a manner that involves only one hand, byeither the clinician or the user.

The present teachings may include designs to facilitate the use of thelead 20 and electrode 18 for testing, a non-limiting example being thelead connector 30 that may electrically and operatively connect theproximal end of the lead 20 to an external stimulator pod 40 via a wire,such as a patient cable 50, quickly and effectively. The patient cable50 may be of any appropriate configuration and may provide astrong/stable mechanical and/or electrical connection. Thisconfiguration may reduce the duration of the procedure to install on thepatient. Being able to easily remove the lead connector 30 also mayreduce the procedure time. A non-limiting example may include a leadconnector 30 having a funnel end 71 such that an end of the lead 20 caneasily be inserted into the funnel 71. The funnel 71 may guide the lead20 into the lead connector area, where teeth, loops, or surfaces thatare spring-loaded may be manipulated by the user via levers or buttonsto clamp onto and create an electrical connection with the lead 20. Thislead connector 30 may have a wire and plug attached with allows forconnection with an external stimulator. The funnel 71 may make it easierto guide a small lead therein. The funnel 71 may guide the proximal endof the lead towards an area where mechanical and electrical connectionwith the electrode may be formed, for example by an internal clipactuated by an external control (e.g., a button, lever, or other meansof controlling a connection).

An exemplary embodiment of the lead connector with a funnel end 71 isshown in FIG. 3C. The funnel 71 may ease insertion of the proximal endof the lead (arrow pointing where lead end would be inserted). The leadconnector 30 may include a button 73 located on a top portion of thelead connector 30, which is a non-limiting example of a mechanism bywhich the actual connection to the lead (internal, not shown) may bemade/controlled. The patient cable 50 may be attached to the leadconnector 50 in any appropriate manner and may allow for easy connectionto the other components such as the simulator pod 40.

The lead connector 30 may eliminate the need for a separate tool. It mayallow a one-handed mechanism for the clinician and/or patient,including, without limitation it may include a push mechanism. The leadconnector 30 may be of any appropriate configuration. By way of anon-limiting example, the lead connector 30 may include plastic unit(e.g., manufactured by insert molding) with an insulation displacementconnector (IDC) mechanism that strips the insulation from the lead 20 inorder to make electrical contact. The lead 20 may be placed in a slot 62with a contact strip with micro-structured barbs that hold the lead 20in place until the IDC mechanism is implemented with a one-handed pushmechanism. The lead connector 30 may also be employed for eachdetachment from (e.g., magnet, spring or other mechanism) andre-attachment.

On the side of the lead connector 30 a breakaway mechanism 54 may beutilized. The breakaway mechanism 54 may include a connector that allowsfor quick detachment and easy re-attachment (e.g., magnet orspring-loaded mechanism). However, the present teachings are not limitedto this configuration. The breakaway mechanism 54 may be operativelyattached with the patient cable 50, i.e., the portion of the lead 20between the lead insertion site and the stimulator pod 40. This mayenable mechanical and/or electrical connection between the lead 20 andpatient cable 50 and/or stimulator pod 40. The breakaway mechanism 54may be of any appropriate configuration that applies a predeterminedforce between a connection point or connection points between the leadconnector 30 and patient cable 50, between portions of the patientcables 50 and/or between the patient cable 50 and stimulator pod 40. Thebreakaway mechanism 54 may be configured such that when a predeterminedforce is applied to the patient cable 50 it becomes dislodged fromeither of the lead connector 30, another portion of the patient cable 50and/or the stimulator pod 40. The breakaway mechanism 54 may comprise amechanical connection, electrical connection, a magnetic connection orany combination of such (a detachable and re-attachable connection),including, without limitation a hook and loop system similar to Velcro.These may operatively interact to provide a predetermined holding forceso that when an amount of force exceeding this predetermined holdingforce the breakaway connector 54 releases. The present teachings are notlimited to a specific configuration.

The breakaway mechanism 54 may use insert molded Neodymium magnets byway of a non-limiting example. In other embodiments, a differentpermanent magnet may be utilized, such as a Samarium Cobalt, Alnico,Ceramic, Ferrite, or other rare earth magnets. In addition or in thealternative, a spring-loaded (or any biasing member) conductive pin(including, without limitation a gold, gold plated, metallic, or anyother conductive material pin) connector may be located on the patientcable 50 and a mating conductive element configured to operativelyengage with the conductive pin may be located on the lead connector 30body. The conductive pin may be formed of any conductive material,including, without limitation being a generally flat gold platedcontact. The conductive pin may be of any configuration and may adjustposition relative to the mating conductive element.

This may provide the predetermined holding force noted above. Thepresent teachings, however, are not limited to this configuration. Anyconfiguration of biasing member may be utilized to apply a predeterminedforce between the lead connector 30 and patient cable 50 (or in thealternative or in addition between portions of the patient cable 50and/or between the patient cable 50 and stimulator pod 40).

The lead connector 30 may eliminate the need for a separate tool—it mayutilize a one-handed push mechanism. Further still, the lead connector30 may include the breakaway mechanism 54 of any appropriate embodimentbetween the patient cable 50 and/or between the patient cable 50 and thestimulator pod 54. Further still, any number of breakaway mechanism 54may be utilized, e.g., one, two, three, etc. Each such breakawaymechanism 54 may be positioned on a different portion of the system,e.g., on the lead connector 30, on the patient cable 50 (any number maybe utilized) and/or on the stimulator pod 40. Multiple breakawaymechanism 54 may be utilized to ensure that the break away occursregardless of where the force is applied.

The lead connector 30 may be configured to enable the adhesive bandage22 to remain secure during use (e.g. locking out water and/orcontaminants) while also enabling safe and easy removal. The leadconnector 30 and adhesive bandage 22 may configured to allow change,application, and/or re-application of the adhesive bandage 22 whileminimizing risk of displacing or dislodging the lead 20, lead connector30, and/or any other system components. The lead connector 30 may matewith the adhesive bandage 22 to eliminate the need for multiple tapesand minimize the fear of lead dislodgement while performing bandagereplacement. Further, the overall system may have a lower profile,including, by way of a non-limiting example having a 30% lower profile.For example, the lead connector 30 may have a low profile that may helpreduce the likelihood of a patient “snagging” or inadvertently catchingthe lead connector 30 on an item. Having the low profile may reduce thechance of this occurring. The lead connector 30 may have a profile thatwhen attached with the patient may extend from the patient slightlymore, even with, or slightly below the adhesive bandage 22.

Additionally or alternatively, the connector 30 may have a rotatingelement, such as a knob, dial, spool or post. The rotating element mayengage the lead 20, mechanically and/or electrically, in order to assistin adjusting the tension of the detachable connection (e.g., thebreakaway mechanism 54) having tension formed by the electrode 18, thelead connector 30 and the patient cable 50. The rotating element mayinclude a predetermined tension release or recoil mechanism thatresponds to a disconnection force by releasing excess lead that is woundaround the element. In the same manner, the lead connector 30 mayaccomplish this tension release by slider or other movement that neednot be rotational in nature. As with the detachable aspects of thepatient cable 50 connections, the tension release may occur at a forcethat is less than or equal to one-half the force required to dislodge ormove the electrode 18 from its initial position.

The lead connector 30 may be bifurcated or split into multiple divisionsto receive a plurality of electrodes 20. For example, multiple slots orfunnels can connect multiple electrodes to a single stimulator pod 40(or a plurality of stimulator pods 40) to enable therapeutic stimulationto be provided to separate parts of the body.

In other embodiments, the connection between the lead connector 30 andpatient cable 50 may be detachable—this detachability may be of anyappropriate configuration, including, without limitation the break awaymechanism 54. The detachability may include, without limitation,magnets, such as insert molded neodymium magnets, that may be formed onthe lead connector 50 and one or both ends of the patient cable 50 (ifon both ends, the stimulator pod 40 would also have a detachableconnection as described herein). Depending on the manufacturing process,the magnets, and how the magnets are fitted together, may allow fordifferentiating the points of connections. For example, the leadconnector 30 may have a stepped connection port that fits with acorrespondingly stepped connection on one of the patient cable, asillustrated in FIG. 4A. Alternatively, a circular magnet may sit on thetop of the connector lead, also shown in FIG. 4B. A slight indentationor groove or other releasable force fitting could be provided to allowfor the experience of a “snap-in” feel. In other embodiments, any matingshapes may be utilized such that the patient or clinician may insert oneportion into another or otherwise engage the two components together—seefor example FIG. 5. Further, the present teachings are not limited tothe shape and size of magnets shown and disclosed. Any appropriate shapeor sized magnet may be utilized in these embodiments. The shape and sizeof the magnets may be the same, mating shape, or different shapes.Further, the breakaway mechanism 54 may not utilize magnets but mayinclude mechanical connections of any type, shape and/or size thatrelease from one another upon application of a specific amount of force.Regardless of configuration, the breakaway mechanism 54 may reduce therisk that force on the patient cable 50 is transferred to the lead 20 ormore specifically to the electrode 18 inserted into the patient. Theconfiguration may allow for easy attaching and easy re-attachment.

In addition to or in place of magnets, a biasing fitting may beutilized—such as a spring-loaded member. The fitting is describedgenerically so that it may be employed on any of the components,although particular utility is expected at the connection between thelead connector 30 and the patient cable 50. End A has an inverted Yshape that mates with a corresponding shaped end B. Additional shapes,prongs or members may be included. The outermost arms C move, such as ina spring-loaded or magnetic fashion, to receive and release end A(single ended arrows indicate a preferred range of motion). Ends A and Bmay be fitted in the plane parallel to the double arrow and/or they maybe dropped or snapped into place and then released in a direction thatis different than, preferably including perpendicular to, the directionof release.

In some embodiments, the break away mechanism 54 may be configured suchthat neither the stimulator pod 40 not the lead 20 (or more specificallythe electrode 18) are displaced if unwanted force is applied to them ortheir connection(s). For example, the connection between the patientcable 50 and the stimulator pod 40 may be detachable upon application ofa predetermined force. The predetermined force may be calculated togenerally prevent movement of the electrode 18 once placed in theappropriate position within the patient.

Alternatively, or in addition, the patient cable 50 may itself bedetachable (e.g. in the middle so that it actually is a plurality ofpatient cables, e.g., 2 or more). The patient cable 50 may be detachableat any point between the lead 20 and the stimulator pod 40, e.g.,patient cable 50 may disconnect at either end. Further still, thepredetermined detachable portion may be between the patient cable 50 andstimulator pod 40, along any portion of the length of the patient cable50. For example, two or more patient cables 50 may be selectivelyattached at a detachment point to disconnect upon application of thepredetermined force. Further, while the present disclosure notes thatthe portions are detachable, they may also be attachable. This may allowthe system to serve as a failsafe mechanism to prevent damage and/orinjury to the system, components, and/or the patient. The detachableportion may comprise the breakaway mechanism 54 described above or anyother kind of appropriate detachable member.

In addition to just safely detaching, the circuitry in any of thepatient cable 50, lead connector 30, and/or stimulator pod 40 mayprevent delivery of unwanted stimulation in the event of a disconnectionduring stimulation, such as when multiple leads and/or patient cablesmay be utilized. By way of a non-limiting example, the patient cable 50may be a “smart cable” that has components in addition to a path forelectrical conduction that minimizes the risk of the patientexperiencing unwanted stimulation (e.g., minimizes or eliminates thepotential for the patient to experience a shock) when the patient cable50 is disconnected unexpectedly during use. For example, the patientcable 50 may, when disconnected from either of the lead connector 30and/or the stimulator pod 40 prevent further stimulation.

All of the above-mentioned connections rely on mated parts. In order toavoid improper installation, each of the mated pairs could be given aunique shape. Sensors or other circuitry may be employed at theconnections points to better enhance the user alert feature describedherein. Such sensors or circuitry could be inherent to the electricalsignal delivering the stimulation, or separate signals could beestablished.

The patient cable 50 may mechanically and/or electrically connect thelead connector 30 and controller pod 40. Any durable, flexible materialmay be used for the patient cable 50. Patient cable 50 may also deliverpower to and/or from the connected elements, or independent powersupplies may be provided. The power supply for the system 10, andparticular the stimulator pod 40 and controller pod 60 may be disposableor rechargeable, and any number of batteries or other power devices(e.g., capacitors, fuel cells, etc.) may be incorporated, depending uponthe form factor and power requirements of the system.

In the event a plurality of patient cables 50 is used to establish aconnection between the electrode/lead connector 30 and the stimulatorpod 40, each segment of the patient cable 50 may rely on the quickrelease connections described above. In this manner, the risk ofunintended force (e.g., snagging on clothing) repositioning ordislodging the electrode 18 is further minimized, particularly if thestimulator pod 40 cannot be placed proximate to the lead connector 30.Utilizing a plurality of segments in the patient cable 50 also improvesthe overall adaptability of the system.

The housing and/or materials selected for the lead connector 30 shouldbe consistent with its design and purpose. At least portions of the leadconnector 30 will be constructed from sufficiently conductive materialto carry electrical pulses and signals from the stimulator pod 40 (suchas via patient cable 50). Magnetic shielding may be selectively employedto minimize the creation of unwanted magnetic fields.

In an embodiment depicted in FIG. 2A, the lead connector 30 may beattached to the body 12. This attachment may be made by way ofadhesives, straps or other means. In one embodiment, at least a portionof the lead connector 30 is engaged by the adhesive bandage 22. The leadconnector 30 may be sufficiently lightweight and/or located insufficient proximity to other system components that are affixed to thebody 12, so that the lead connector 30 may simply move freely as part ofthe detachable connection having tension formed by the electrode 18, thelead connector 30 and the patient cable 50. As shown in FIG. 6, atemporary tape strip 61 may be utilized to hold the lead connector 30 inplace so as to operatively attach the break away mechanism 54. Thetemporary tape strip 61 may not be utilized in some embodiments.

The stimulator pod 40 may contain a programmable memory unit andcircuitry necessary to deliver the therapeutic stimulation inherent tosystem 10. Further, the stimulator pod 40 may be designed to eliminatethe need for a separate return electrode. The stimulator pod 40 may alsocontain a graphical user interface to communicate with the user. Thestimulator pod 40 may include an LED or other visual indicia tocommunicate actions, errors or other pertinent information about theoperation of the system. The stimulator pod 40 may also allow for userand/or clinician adjustments to the operation of the system. Furtherstill, the stimulator pod 40 may communicate with a controller unit,either via a physical or wireless connection. Cables, wires, Bluetoothand other wireless technologies are all expressly contemplated. In someembodiments, the controller pod 60 may either have or not have a userinterface integrated with it and/or remote (e.g. wireless such asBluetooth). The present teachings are not limited to any suchconfiguration.

The controller pod 60 may provide a more extensive graphical userinterface, and it may be the primary means of initiating and alteringthe therapy, however, the present teachings are not limited to such. Aswith the stimulator pod 40, controller pod 60 may communicate viaphysical wires/cables or wirelessly with the stimulator pod 40 (or pods,if multiple pods are included in the system) and the optional programmerunit 70, described below. The controller pod 60 may be relatively largerthan the stimulator pod 40, although wireless connectivity may allow theuser to carry the controller pod 60 in clothing and/or generally at aconvenient distance and location in comparison to the electrode 18 andstimulator pod 40.

While the stimulator pod 40 and controller pod 60 may both have a lowprofile and lightweight features, the programmer unit 70 may be a fullycapable computer that can transmit detailed therapeuticinstructions/regimens, error logs, usage logs and/or other informationgenerated by the system 10. In some embodiments, the programmer unit 70may remain in possession of the clinician, insofar as it enables a widerrange of therapies, and the mobile and portable aspects of the othercomponents in system 10 are inherent only to the user. The programmerunit 70 may communicate with the stimulator pod 40 directly orindirectly via the controller pod 60.

By way of example rather than limitation, the system 10 is expected tohave particular utility in the treatment of post-stroke shoulder pain byway of percutaneous stimulation via a fine-wire lead in the deltoidmuscle to stimulate branches of the axillary nerve. The therapy isdelivered for a period of time, after which the lead is removed usinggentle traction. The duration of daily therapy may range between 1 and12 hours, with 6 hours as a preferred duration. The daily therapy may beadministered over a period of days, weeks or even months, with 30 daysanticipated to have the most benefit. The stimulation pulses andparameters may be varied, but the preferred range is less than 25 Hz,with some therapies particularly effective in the range bounded byseparate lower and upper limits selected from: 1, 5, 10, 12, 15, 18 and20, although other limits are contemplated. The amplitude is preferablycentered at 20 mA, although any value between up to 50 mA or more may beuseful. The pulse durations last anywhere from 5 microseconds to 200microseconds or more, with minimal average pulse duration of 32 μs(range: 5 μs-75 μs); optimal average pulse duration of 70 μs (range: 10μs-150 μs); and maximum tolerable average pulse duration of 114 μs(range: 25 μs-200 μs). Notably, tests have shown that electricalstimulation according to the system 10 for this purpose has both shortterm and long-term benefits that are not fully realized by thealternative treatment methods noted above.

While post stroke shoulder pain application is described above, thepresent teachings are not limited to any specific treatment orindication. It may apply to any kind of treatment, including, withoutlimitation post-surgical pain patients or any type of pain patients,especially chronic pain patients (e.g. neuropathic pain, headache,and/or back pain patients).

Additional embodiments of a percutaneous stimulation system accordingthe present teachings are described below. In the descriptions, all ofthe details and components may not be fully described or shown. Rather,the main features or components are described and, in some instances,differences with the above-described embodiment may be pointed out.Moreover, it should be appreciated that these additional embodiments mayinclude elements or components utilized in the above-describedembodiment although not shown or described. Thus, the descriptions ofthese additional embodiments are merely exemplary and not all-inclusivenor exclusive. Moreover, it should be appreciated that the features,components, elements and functionalities of the various embodiments maybe combined or altered to achieve a desired percutaneous stimulationsystem without departing from the spirit and scope of the presentinvention.

A lead connector 130 may be designed to couple to the percutaneous leadeasily. In a non-limiting example, the lead may be inserted through anaperture 131 in the lead connector, and the lead may go throughpartially or completely through the aperture 131. The aperture 131 mayinclude a funnel shape where the lead is inserted to enable easyinsertion into the aperture—See FIG. 12. In another non-limitingexample, the lead may be placed into a slot or channel in the leadconnector 130. In another non-limiting example, the lead connector maybe composed of two or more components with the lead placed betweenand/or within the components, and the components may be secured together(e.g., slid together, snapped in place, twisted/screwed onto oneanother, etc.) to couple to the lead. In some embodiments, the leadconnector 130 may enable easy one-handed insertion and coupling of thelead to the system while remaining mechanically and electrically secureand prevents the patient from decoupling the lead (or electrode)intentionally or unintentionally.

The lead may be coupled to the lead connector electrically andmechanically. The mechanism by which the lead may be coupledmechanically to the lead connector 130 may be separate or the same asthe mechanism by which the lead is coupled electrically to the leadconnector 130. The user may couple the lead to the lead connector 130using a component including, but not limited to, a knob, button, switch,or dial.

The lead connector 130 may be decoupled from the lead, and may allow thelead to be reconnected to the lead connector 130 at a different pointalong the lead (e.g., closer to or farther away from the stimulatingportion of the lead or electrode). In a non-limiting example, the leadconnector 130 may include a lock to prevent the patient fromdisconnecting the lead. The lock may be opened using, for example (butnot limited to), a key, a tool (e.g., torque wrench), a code (e.g.,combination) or without a tool. In another non-limiting example, thelead connector 130 may minimize or eliminate damages or changes to thelead's structure, enabling the lead to remain sufficiently intact togenerally reduce the risk of the lead fracturing or breaking and enablecurrent flow through the entire lead.

A lead connector 230 may include a lead storage mechanism 233 to store alead 220 (e.g., while the lead is coupled to the lead connector 230).This mechanism may reduce the excess length of lead 220 between the leadconnector 230 and the point from which the lead 220 exits the body. Thismay reduce the risk of the lead 220 being caught on an object and beingpulled and/or breaking. If the lead 220 is caught, for example, on anexternal object or from a body part, then the excess lead 220 stored onthe mechanism may be released rather than dislodging or moving the lead220 from the tissue, fracturing the lead 220 (inside or outside thebody), and/or pulling the lead 220 out and decoupling from the leadconnector 230. In a non-limiting example, the mechanism 233 may be aspool around which the lead 220 is wound, either manually orautomatically (e.g., using a spring). In another non-limiting example,the mechanism 233 may be located on the outside of the lead connector230 or within the lead connector 230—See FIGS. 13 and 14. In addition,the lead connector 230 may be padded on one or more sides to providecomfort while wearing the lead connector 230.

A lead connector 330 may be designed to couple to the stimulator pod 40easily, and may enable connection using a single hand. In a non-limitingexample, the lead connector 330 may be connected to the stimulator pod40 via a patient cable 350. In a non-limiting example, the patient cable350 may connect to the lead connector 330 through a connection 357, suchas by way of a non-limiting example a magnetic connection. It should beunderstood, however, that while a magnetic connection is described, theconnection may be any mechanical connection in addition to oralternatively to the magnetic connection. The connection 357 may beoriented at various angles with respect to the surface of the skin. In anon-limiting example, the connection 357 is oriented generallyperpendicular to the skin. In another non-limiting example, theconnection 357 is generally parallel to the surface of the skin. In yetanother embodiment, the connection 357 may be easy for the user to make(e.g., does not require great dexterity, may be connected even withoutlooking at the connectors) and strong enough to prevent inadvertentdisconnection (e.g., due to common body movements or small forces, etc.)while disconnecting when subjected to stronger forces that may dislodgethe lead (e.g., from external objects or body parts pulling or tuggingon the lead connector or stimulator attached to the lead connector). Theconnection 357 may prevent the lead 320 from dislodging or fracturing bydisconnecting the lead connector 330 and cable when the patient cable350 is pulled rather than transmitting the force along the lead 320—SeeFIGS. 15 and 16. In some embodiments, the connector 357 may include twoportions a positive 357 a and negative 357 b portion of a magnet thatattract to one another at a predetermine force. It should be understoodthat the positive portion may be on either side 357 a or 357 b and thenegative portion may be on either side 357 a and 357 b. Further stillone portion may be a magnet (357 a or 357 b) and the other side may be amaterial attracted by the magnet (357 a or 357 b). In a non-limitingexample, the magnetic connectors 330 may be structured such that thesurrounding magnetic field is reduced and avoids interfering withobjects placed near the magnetic connectors (e.g., credit cards, cellphones).

Further still, the lead 320 may connect directly to the stimulator pod40 (i.e., lead connector may be built into or integrally with thestimulator pod). The stimulator pod may be placed directly over oradjacent to the lead exit site to protect the exit site. There may be aclear window through which the lead exit site can be monitored forsafety (e.g., infections, irritation).

In another non-limiting example, the patient cable 450 may connect tothe lead connector 430 using a jack 457 b and plug 457 a, and the jack457 b may be located on the patient cable 450 and oriented at an angle(such as 90 degrees) to the patient cable 450. This jack 457 b may beconnected to the plug 457 a on the lead connector 430 using a downwardforce, enabling connection using a single hand. The very small distancesbetween the magnetic armature of the plug 457 a and the permanent magnetstructure of the lead connector 430 means that the residual fieldoutside the lead connector 430 is very small—see FIG. 16.

As shown in FIG. 17, a patient cable 550 may attach to the stimulatorand stored or organized (e.g., wound, coiled, wrapped around) to reducethe length of the patient cable 550 (or lead 520) that may becomecaught, for example, on an external object or a body part. In anon-limiting example, the excess patient cable 550 may be stored in astorage device 551 attached to the cable 550, on the lead connector 530,and/or on the stimulator pod 540. In a non-limiting example, the storagedevice 551 is a spool around which the patient cable 550 may be woundmanually or automatically (e.g., via a spring). In an embodiment, thepatient cable 550 may be coiled or wound around a spool on thestimulator pod 540, and forces on the patient cable 550 cause thepatient cable 550 to be uncoiled from the spool rather than disconnectfrom the stimulator pod 540, transmit the force to the lead connector530, and/or patient cable 550—See FIG. 17.

The stimulation system may contain patient cable that attach to thestimulator pod available in multiple lengths. In a non-limiting example,the patient cable with the shortest length that enables connectionbetween the stimulator pod and the lead connector may be selected toreduce the risk of the patient cable catching on an object or body partand disconnecting the system, dislodge the lead, and/or fracture thelead.

As shown in FIG. 18, two or more patient cable 650 may be used toconnect the stimulator pod 640 to the lead connector 630. The use ofmore than one patient cable 650 to connect to the stimulator pod 640 mayenable more control of the total length of cabling between the leadconnector 630 and stimulator pod 640 (e.g., compared to the use of asingle cable with a fixed length). In a non-limiting example, eachindividual patient cable 650 may be short (e.g., <1-2 inches), which mayenable more precise control over the total length of the multiple cablesconnected together. In another non-limiting example, patient cables 650may be available in different lengths. In a non-limiting example,multiple patient cable 650 may be connected together, and the minimumnumber of cables are used to connect the lead connector 630 to thestimulator pod 640 to minimize the total length of cable, thus reducingthe risk of the cables catching or snagging (e.g., on an external objector a body part)—See FIG. 17. Each of the patient cables 650 may beattached utilizing a breakaway mechanism 654 of any configuration, suchas that described above. Each patient cable 650 may include a breakawaymechanism 654 attached to each end thereof. The breakaway mechanism 654may connect to one another and/or the lead connector 630 and/or thestimulator pod 640 such that they remain connected upon applicable of apredetermined force. If the force applied exceeds this predeterminedforce any of or a plurality of the breakaway connectors 654 may becomedisconnected. This prevents the electrode from moving from within thepatient. The breakaway connectors 654 may also be easy to attach oncethey have become disconnected. The breakaway connector 654 may utilizemagnets, bayonet attachment, biasing force, friction fit, etc. toconnect together. Any appropriate configuration may be utilized.

In some embodiments, the stimulator pod may enable coordinatedstimulation across two or more stimulator pods. In the alternative or inaddition, the controller pod and/or programmer unit may enablecoordinated stimulation across two or more stimulator pods. Coordinatedstimulation may enable stimulation across multiple stimulator pods tostart and stop in a coordinated manner to avoid asynchronous activationof muscle on opposite sides of the body (e.g., the back or torso), whichmay cause loss of balance or discomfort. Control over stimulation acrossmultiple stimulator pods may also prevent synchronized stimulation, forexample, to avoid activation of opposing muscles (e.g., biceps andtriceps), which may cause discomfort. In a non-limiting example, one ofthe stimulator pods, controller pod and/or programmer unit maycommunicate with other stimulator pods directly. In another non-limitingexample, each stimulator pods may be connected to a central controllingunit, which may be another stimulator pod or may be a non-stimulatingcontrol unit. In a non-limiting example, communication among stimulatorpods and/or control units (controller pod or programmer unit) may bewireless (e.g., via Bluetooth, WI-Fi) or wired (e.g., cables).

The stimulator pod may provide simple programming of stimulationintensity by controlling stimulation amplitude and pulse duration with asingle programmable parameter for intensity. Stimulation intensity isdetermined by multiple parameters, including (but not limited to)stimulation amplitude and pulse duration. For example, stimulationintensity may be increased by increasing stimulation amplitude, pulseduration, or a combination of the two. Controlling multiple parameterssuch as stimulation amplitude and pulse duration using a singleparameter may reduce the complexity of the procedure to programstimulation parameters by reducing the number of parameters that can bechanged from 2 or more to 1. As a non-limiting example, the minimum ofthe stimulation intensity parameter (e.g., 0) may set the stimulationamplitude and pulse duration to their lowest values (e.g., 0.2 mA and 10microseconds). As another non-limiting example, increasing thestimulation intensity parameter may change the stimulation amplitude,the pulse duration, or both.

In yet another embodiment, increasing the stimulation intensityparameter from the minimum value may first increase the stimulationamplitude while keeping the pulse duration at a minimum until themaximum value of the stimulation amplitude (e.g., 20-30 mA) is reached.Then, continuing to increase the stimulation intensity parameter maykeep the stimulation amplitude fixed at the maximum value whileincreasing the pulse duration until the maximum value of the pulseduration is reached. In these embodiments, stimulation intensity issimple to program and may be increased while keeping pulse duration aslow as possible. This keeps the stimulation charge required to activatenerve fibers as low as possible and increases the ability to selectivitystimulation large diameter fibers over small diameter fibers. In anothernon-limiting example, increasing the stimulation intensity parameterfrom the minimum value may first increase the stimulation amplitudewhile keeping stimulation amplitude at a minimum. Then, continuing toincrease the stimulation intensity parameter beyond the maximum value ofpulse duration (e.g., 200 microseconds) may keep the pulse durationfixed at the maximum value while increasing the amplitude until themaximum value of the stimulation amplitude is reached. In this example,stimulation intensity increases while keeping stimulation amplitude aslow as possible, which keeps the power consumption of the pulse as lowas possible for a given charge per pulse. Left column of FIG. 19 is thefirst example given, keeping pulse duration low. The right column ofFIG. 19 is the second example, keeping stimulation amplitude low.

In another non-limiting example, a lead connector may be attached to thelead prior to or after insertion of an introducer system, enablingstimulation through the lead tip during the lead placement procedure. Inone embodiment, the connector may be attached to the lead by droppingthe lead into a slot or hole on the block and closing a flap whichimplements an insulation displacement connection (e.g., cutting throughthe insulative material aside to form a connection with the conductivelead wire). This lead connector may improve the speed and ease of leadconnection because it can be attached without the use of tools (e.g., nowire cutters, scissors, and screwdrivers). For example, in thisembodiment, the lead may be placed into a slot in a lead connector blockand secured using a lockable, reversible one-handed mechanism todisplace the insulation on the lead body. The insulation displacementmechanism inside the lead connector may also cut the lead distal to theelectrical connection. Once the connection has been made and the excesslead is trimmed, a lock (e.g., sliding, twisting, button press) mayensure that the flap on the block cannot be reopened accidentally. Thisfeature prevents loss of connection between the lead connector and lead,which would result in loss of therapeutic benefit. The lead connectormay mate with another lead connector (e.g., patient cable or plug to thestimulator pod) to complete the circuit from the stimulator pod to thelead tip electrode.

In one embodiment, the connection between the two lead connectors may bemagnetic. In this case, the shape of the lead connectors will preventimproper alignment of the lead connector (e.g., lead connectors thatonly fit together in one orientation). The magnetic connection may beused for both temporary and permanent stimulation delivery (e.g., duringlead placement procedure or during patient's home use of the therapy).After obtaining proper lead placement location, the lead connector blockmay be removed and replaced following removal of the introducer systemneedle(s) and sheath(s). In one embodiment, the connection may bedeactivated by pressing or sliding open the slot that contains the lead.In this example, the lead connector block may be removed or cut offprior to removal of the introducer and then quickly re-attached to amore proximal location on the lead. Following removal of the introducer,the lead may be placed in the slot and connected with a one-touchmechanism (e.g., pressing, sliding) and then the lead connector may beattached to the stimulator cable.

The magnetic connection may act as a quick-release connection that willprevent accidental lead (or electrode) dislodgement due to a pulled leadand/or patient cable. Instead of transferring force to the lead exitsite and lead, any forces on the patient cable will be discharged due tothe breaking of the magnetic connection between the patient cable andlead connector block. If desired by the clinician, a permanentconnection may be made by locking the two-connector pieces togetherusing a press button lock (or any other suitable lock). In addition tomating with the lead connector block, in another embodiment, themagnetic cable connector for the stimulator pod may also mate with anidentical version of the lead connector block, which is connected to thetest stimulator via a cable. In another embodiment, the magnetic cableconnector originating from the stimulator pod may be bifurcated toconnect with multiple lead connector blocks (e.g., to enable stimulationof two leads with one stimulator).

A battery-operated, body-worn stimulator pod may generate electricalcurrent that may be administered via the lead and/or introducer. In oneembodiment, the stimulator pod is a small pod (e.g., with roundedcontours and of minimal profile height) that is worn on the body via agel patch electrode that serves as the return electrode and is connectedwith two snaps that also provide electrical connection. In oneembodiment, the stimulating pod has a minimal user interfaces (e.g., apress button start/stop, LED lights and a speaker or buzzer) to providecritical feedback to the patient. For example, the lights may blink orlight up (e.g., different colors or different flashing patterns) if thebattery is low or if there is a problem with stimulation. This importantfeedback will alert the patient or clinician to address any issues, suchas battery failure, gel pad detachment, or open connection. In thenon-limiting example with a magnetic lead connector, it is importantthat the stimulator pod produces an alert if the quick-release cable isaccidentally dislodged without the patient's knowledge. Additionally,lead errors that cause stimulation to stop due to, for example, highelectrode impedance issues (e.g., due to lost connection between skinand return electrode), and can impact therapy usage time and therapeuticbenefit received by the patient and the audible or visible alert of thestimulating pod prevents this. Further, in one embodiment, thestimulator memory will generate an activity log for documenting usage ofthe stimulator and errors during therapy. The stimulator log may includea list of errors that occurred, along with timestamps of the time thaterrors occurred, a history of usage time, including amplitude andstimulation parameter settings used. These features are important toensure that patients are able to effectively use the stimulation andthat clinicians can effectively monitor their stimulation usage.

Exemplary embodiments of the IDC are depicted in FIGS. 20 and 21. An IDC705 shown in FIG. 20 may include a drawer type mechanism or disc 708that is insertable into the body of the IDC 705 and removable therefrom.A slot 710 of any appropriate shape and size to firmly hold or engagethe lead 720 may be positioned within the disc 708. A user may push thedisc 708 to rotate such and move the lead 720 fully inside the IDC 705.The IDC may be integral with or attached to the lead connector. Barbs(not shown) may be included in the interior of the IDC 705 if necessaryto remove insulation from the lead 720 to expose the underlying wire.

In another embodiment shown in FIG. 21, an IDC 805 may have a generallycylindrical shape. The IDC may include an aperture, slot or opening 807into which the lead 820 may be inserted. The IDC may include anactuating lever to rotate the IDC until the lead 720 is fully inside theIDC. Barbs (not shown) may be included in the interior of the IDC 805 ifnecessary to remove insulation from the lead 820 to expose theunderlying wire.

An additional embodiment of a breakaway mechanism 954 is shown in FIGS.22-25. In FIG. 22, a portion of the breakaway mechanism 954 is shown asa receptacle portion 956. The receptacle portion 956 may include amagnet 958 of any appropriate embodiment that includes a contact point959. The receptacle portion 956 may include an iron magnetic stator 960,which may act as a pathway keeper. FIG. 23 depicts a mating portion ofthe breakaway mechanism 954, which is a plug 962. The plug 962 mayinclude an iron magnetic keeper path 964 and a contact 966. The patientcable 950 may be operatively attached with the plug 962.

As shown in FIG. 24, the breakaway mechanism 954 may include a springloaded plunger mechanism 974. The plunger mechanism 974 utilizes a pairof biasing member 977 that may push plungers 975 toward each other asthe plug 962 is inserted into the receptacle 956. This may secure thebreakaway mechanism 954 together. The force utilized to keep thebreakaway mechanism 954 together is defined such that any amount offorce applied to the system that exceeds such force will cause the plug962 to separate from the receptacle 956, e.g., if there is a forceapplied to the patient cable 950 because it snags on something. Thiswill generally protect the system. In particular, it generally preventsthe lead and/or electrode from becoming disengaged or moved from theirintended position.

Although the embodiments of the present teachings have been illustratedin the accompanying drawings and described in the foregoing detaileddescription, it is to be understood that the present teachings are notto be limited to just the embodiments disclosed, but that the presentteachings described herein is capable of numerous rearrangements,modifications and substitutions without departing from the scope of theclaims hereafter.

We claim:
 1. An electrical stimulation system comprising: a lead connector comprising a body having at least one slot or channel and a contact element proximate to at least portion of the slot or channel; a coiled lead inserted into said slot or channel, wherein the contact element establishes an electrical connection with the coiled lead and wherein the coiled lead has an engagement force when inserted into a body of a patient; a patient cable selectively attachable to the body, wherein the contact element establishes an electrical connection with the patient cable; and wherein the lead connector further comprises a breakaway mechanism configured to selectively disconnect the patient cable from the body upon application of a force exceeding a predetermined force, wherein the predetermined force is less than the engagement force.
 2. The electrical stimulation system of claim 1 further comprising an electrical stimulator operatively attached with the patient cable, wherein the electrical stimulator is configured to apply electrical stimulation.
 3. The electrical stimulation system of claim 2, wherein the contact element includes micro-structured barbs to engage the coiled lead.
 4. The electrical stimulation system of claim 2, wherein the breakaway mechanism comprises a Velcro-style, hook and loop attachment.
 5. The electrical stimulation system of claim 2, wherein the breakaway mechanism comprises a neodymium magnet.
 6. The electrical stimulation system of claim 2, wherein the breakaway mechanism comprises at least one of: a rare earth magnet, a samarium cobalt magnet, an alnico magnet, a ceramic magnet, and a ferrite magnet.
 7. The electrical stimulation system of claim 2 further comprising an insulation displacement device proximate to the slot or channel, said insulation displacement device engaging the coiled lead to remove any electrical insulation therefrom as or after the coiled lead is inserted into the slot or channel.
 8. The electrical stimulation system of claim 7, wherein the contact element comprises micro-structured barbs to temporarily engage the percutaneous coiled lead as or before electrical insulation is removed from the percutaneous coiled lead.
 9. The electrical stimulation system of claim 2, wherein a spring-loaded, conductive pin carried on the patient cable engages a mating element formed on the body, said engagement of the mating element with the patient cable creating an electrical connection between the coiled lead and the patient cable by way of the contact element.
 10. The electrical stimulation system of claim 2, wherein a spring-loaded, conductive pin formed on an exterior facing of the body engages a mating element formed on the patient cable, the engagement of the pin with the patient cable creating an electrical connection between the coiled lead and the patient cable by way of the contact element.
 11. The electrical stimulation system of claim 2 further comprising an adhesive bandage mated to the body wherein a profile of the body is even with or below a thickness of the adhesive bandage.
 12. The electrical stimulation system of claim 2, wherein the body includes a connection point for attachment to the patient cable.
 13. The electrical stimulation system of claim 12, wherein the connection point has an inverted Y shape.
 14. The electrical stimulation system of claim 12, wherein the connection point has a plurality of movable arms.
 15. The electrical stimulation system of claim 12, wherein the connection point has a biasing fitting.
 16. The electrical stimulation system of claim 1, wherein the body includes a releasable force fitting comprising a groove or indentation.
 17. The electrical stimulation system of claim 2, wherein the lead connector comprises a rotating element engageable with the coiled lead, the rotating element configured to adjust the engagement force.
 18. The electrical stimulation system of claim 17, wherein the rotating element comprises at least of a knob, dial, spool or post.
 19. The electrical system of claim 2, wherein the lead connector is bifurcated into multiple divisions to receive a plurality of coiled leads.
 20. The electrical system of claim 19 further comprising a plurality of coiled leads.
 21. The electrical system of claim 20, wherein the lead connector comprises a lead storage mechanism, wherein the lead storage mechanism reduces a length of the coiled lead extending from the lead connector.
 22. The electrical system of claim 21, wherein the lead storage mechanism comprises a spool.
 23. An electrical stimulation system comprising: a lead connector comprising a body comprising at least one funnel shaped end; a coiled lead inserted into said funnel shaped end, wherein the lead connector establishes an electrical connection with the coiled lead and wherein the coiled lead has an engagement force when inserted into a body of a patient; a patient cable selectively attachable to the body, wherein the lead connector establishes an electrical connection with the patient cable; and wherein the lead connector further comprises a breakaway mechanism configured to selectively disconnect the patient cable from the body upon application of a force exceeding a predetermined force, wherein the predetermined force is less than the engagement force.
 24. The electrical stimulation system of claim 23, wherein the lead connector comprises a rotating element engageable with the coiled lead, the rotating element configured to adjust the engagement force.
 25. The electrical stimulation system of claim 23 further comprising an electrical stimulator operatively attached with the patient cable, wherein the electrical stimulator is configured to apply electrical stimulation.
 26. The electrical stimulation system of claim 23, wherein the contact element includes micro-structured barbs to engage the coiled lead.
 27. The electrical stimulation system of claim 23, wherein the breakaway mechanism comprises a neodymium magnet.
 28. The electrical stimulation system of claim 23, wherein the breakaway mechanism comprises at least one of: a rare earth magnet, a samarium cobalt magnet, an alnico magnet, a ceramic magnet, and a ferrite magnet.
 29. The electrical stimulation system of claim 23, wherein a spring-loaded, conductive pin carried on the patient cable engages a mating element formed on the body, said engagement of the mating element with the patient cable creating an electrical connection between the coiled lead and the patient cable by way of the contact element.
 30. The electrical stimulation system of claim 23, wherein a spring-loaded, conductive pin formed on an exterior facing of the body engages a mating element formed on the patient cable, the engagement of the pin with the patient cable creating an electrical connection between the coiled lead and the patient cable by way of the contact element.
 31. The electrical stimulation system of claim 23, wherein the body includes a connection point for attachment to the patient cable.
 32. The electrical stimulation system of claim 31, wherein the connection point has an inverted Y shape.
 33. The electrical stimulation system of claim 31, wherein the connection point has a plurality of movable arms.
 34. The electrical stimulation system of claim 31, wherein the connection point has a biasing fitting.
 35. The electrical stimulation system of claim 23, wherein the body includes a releasable force fitting comprising a groove or indentation.
 36. The electrical stimulation system of claim 24, wherein the rotating element comprises at least of a knob, dial, spool or post.
 37. The electrical system of claim 23, wherein the lead connector is bifurcated into multiple divisions to receive a plurality of coiled leads.
 38. The electrical system of claim 37 further comprising a plurality of coiled leads.
 39. The electrical system of claim 23, wherein the lead connector comprises a lead storage mechanism, wherein the lead storage mechanism reduces a length of the coiled lead extending from the lead connector.
 40. The electrical system of claim 39, wherein the lead storage mechanism comprises a spool. 